Summary:
Summary Statement of Deficiencies D1002 REPORTING OF SARS-CoV-2 TEST RESULTS During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: Findings: During an onsite recertification survey performed on 01/20/2022, based on testing personnel interview and lack of documentation, the laboratory failed to report negative SARS-CoV-2 test results to the South Carolina Department of Health (SCDHEC) in such form and manner, and at such timing and frequency, as defined in 400.200 CFR for 2 of 2 years reviewed (2020 and 2021). Findings include: 1. Documentation regarding the submission negative SARS-CoV2 results to SCDHEC was unavailable for review on the day of the survey for 2 of 2 years reviewed (2020 and 2021). 2. Testing personnel confirmed during an onsite survey on 01/20/2022 that the laboratory did not report negative SARS-CoV-2 test results back to SCDHEC as required by federal law. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --